1. Field of the Invention
The present invention relates to a device for retaining a catheter, such as a gastrostomy or jejunostomy feeding tube, in place with respect to the skin of a patient. The present invention also relates to a catheter assembly and a method of using the same.
2. Description of Related Art
It is common practice in health care facilities or the like for an elongate flexible tube, generally known as a catheter, to be inserted percutaneously in a patient to assist in medical treatment. Such catheters are used in a variety of applications to inject fluids into or withdraw fluids from the canals, vessels, passageways or body cavities of a patient. Catheters also can be used to maintain an orifice or similar passage in an open condition.
For example, numerous patients receiving medical treatment are unable to ingest foods orally due to conditions such as facial injuries, esophageal injuries, or unconsciousness. Liquid nutritional products therefore have been developed for a process known as enteral feeding. Enteral feeding typically involves the insertion of a feeding tube percutaneously into the gastrointestinal tract of a patient, such as the stomach or intestine. To prevent injury to the patient and the feeding assembly, it is advantageous to retain the placement of the feeding tube relative to the skin of the patient. A variety of retaining devices have been developed for this purpose.
FIG. 1 demonstrates, for purpose of illustration only, a known catheter or feeding tube assembly including a gastrostomy tube 10 inserted percutaneously in a patient for the introduction of a liquid nutritional product. The gastrostomy tube 10 extends through the epidermis 11, the fat layer 12, the muscle layer 13, the peritoneum 14, the stomach lining 15, and the gastric mucosa 16. One end 17 of the gastrostomy tube is located within the stomach. An internal retaining member 18 is fastened proximate one end of the gastrostomy tube and located within the stomach, adjacent to the mucosa wall 16. The internal retaining member 18 thereby reduces the possibility of inadvertent removal of the gastrostomy tube from the patient. As shown in FIG. 1, the internal retaining member can be an inflatable or expandable membrane, although it also is known to use a flange-type internal retaining member if desired. Furthermore, it is noted that catheter assemblies used for other applications, such as for jejunostomy or intravenous applications, may not require an internal retaining device.
The known feeding tube assembly of FIG. 1 further includes an external retaining device 19 located externally of the person adjacent to the epidermis 11. This particular external retaining device generally is a disk-shaped member having a cylindrical opening formed therethrough to maintain the feeding tube substantially perpendicular to the patient's skin. Similar external retaining devices are available for use with enteral feeding tubes distributed by Sandoz Nutrition Corporation, 5320 West Twenty Third Street, P.O. Box 370, Minneapolis, Minn. 55440, U.S.A., under trade names such as CALUSO.RTM. PEG and SUPER PEG.TM.. Although the Sandoz external retaining device has a circular base portion, other shapes can be used, as demonstrated by U.S. Pat. No. 5,071,405. Because the feeding tube extends perpendicularly from the patient, this known feeding tube assembly can be susceptible to entanglement. To minimize such entanglement, it is advisable that the tube of this feeding tube assembly be wrapped or twisted into a loop. Care must be taken, however, to ensure that subsequent pulling or tugging does not kink the loop and thus occlude flow through the tube.
Several concepts for external retaining devices, which are also known in the medical device industry as skin disks, have been developed in an attempt to minimize or eliminate the disadvantages of the prior art design. Particularly, U.S. Pat. No. 5,267,969 discloses an external retaining device configured to receive a feeding tube extending substantially perpendicularly from a patient and then guide the feeding tube through a 90.degree. bend without being kinked. The external retaining device of U.S. Pat. No. 5,267,969 includes a first hole to receive the feeding tube and a second hole of a larger diameter having a center axis arranged coplanar with but perpendicular to the center axis of the first hole. Although effective for its intended purpose, it has been found that this external retaining device can be difficult to adjust in position once properly placed against the patient with the feeding tube extending therethrough.
In view of the above, there remains a need for a readily adjustable external retaining device capable of bending and retaining a catheter in position against a patient without being kinked or occluded. Furthermore, there remains a need for a feeding tube assembly including this improved external retaining device and a method of using the same.